NCT03767244

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,517 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Apalutamide	Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
DRUG	Androgen Deprivation Therapy (ADT)	Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter \[ng/dL\]).
DRUG	Placebo	Participants will receive matching placebo oral tablets daily.

Timeline

• Start date: 2019-06-11
• Primary completion: 2026-12-01
• Completion: 2028-10-13
• First posted: 2018-12-06
• Last updated: 2026-04-13

Locations

203 sites across 18 countries: United States, Argentina, Australia, Brazil, Canada, Czechia, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study